MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-14 for CIRCON LAP-10-ON LAPAROSCOPE G96-LIGHT CORD manufactured by Circon.
[16401505]
The light cord connector became very hot and when placed on a folded blue towel smoke was noted and a burn the size of a pea was noted on the towel. Immediate action to remove the cord and no further damage or injury to pt occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 83000 |
| MDR Report Key | 83000 |
| Date Received | 1997-04-14 |
| Date of Report | 1997-03-14 |
| Date of Event | 1997-03-04 |
| Date Facility Aware | 1997-03-04 |
| Report Date | 1997-03-14 |
| Date Added to Maude | 1997-04-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCON |
| Generic Name | LAPAROSCOPE TELESCOPE AND CORD |
| Product Code | EQH |
| Date Received | 1997-04-14 |
| Returned To Mfg | 1997-03-14 |
| Model Number | LAP-10-ON LAPAROSCOPE |
| Catalog Number | G96-LIGHT CORD |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 82370 |
| Manufacturer | CIRCON |
| Manufacturer Address | 300 STILLWATER PO BOX 1971 SATAMFORD CT 069041971 US |
| Baseline Brand Name | HIGH TRANSMISSION AUTOCLAVABLE LIGHT GUIDE |
| Baseline Generic Name | LIGHT GUIDE |
| Baseline Model No | G96 |
| Baseline Catalog No | G96 |
| Baseline ID | NA |
| Baseline Device Family | LIGHT GUIDE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-14 |